Method and limits
This site is a mechanical filter, not an analysis. Here is exactly what it does and does not do.
Where the text comes from
Every quotation is taken from the Summary of Product Characteristics (SmPC) of the product, as published on the electronic Medicines Compendium (emc) at medicines.org.uk, which carries the UK regulatory label. The link at the bottom of each product page goes to that document. Where the emc page shows a "last updated" date, that date is shown here.
How a briefing is built
- The manufacturer's full Summary of Product Characteristics is read, section by section, for that one product.
- Every statement worth knowing is written out as a single line, and tagged with the section number it comes from - composition, posology, contraindications, warnings, interactions, pregnancy, undesirable effects, pharmacology, excipients, storage.
- Those lines are grouped under five headings: ingredients and materials, manufacture and storage, safety findings, evidence and claims, and what the document itself concedes.
- Nothing is added from any other source: no other product, no news, no study that is not in the document, and no opinion about whether anything is good or bad.
A product page also carries two supporting layers, both built mechanically from the same document:
- The verbatim ingredient lists - section 2 and section 6.1, word for word, with a plain-English note on what each thing is.
- The audit trail - every sentence in the document that contains one of the phrases below, in the document's own words, so you can check the briefing against the raw material and see that nothing was left out.
The phrase lists used for the audit trail
These do not select what goes in the briefing. They only decide which sentences are copied into the audit trail, matched as whole words.
No data / not studied
The document itself states that something was never tested, measured or established.
are unknownhas not been demonstratedhas not been evaluatedhas not been studiedhave not been establishedhave not been evaluatedhave not been studiedis unknownno datano informationno studiesnot been assessednot been characterisednot been characterizednot been determinednot been establishednot been evaluatednot been fullynot been investigatednot been studiednot known
Limited, insufficient or inconclusive
The document itself describes the evidence as limited or says a conclusion could not be reached.
could not be establishedcould not be madeinsufficientlimited availablelimited datalimited experiencelimited informationno conclusionnot possiblenot predictableremains unknownuncertainwide confidence interval
Rare or very rare serious events
Events the document lists as rare, very rare, or otherwise serious, including post-marketing reports.
acute disseminatedanaphylaarthritisbell's palsybrachialconvulsiondeathdeathsencephalfatalguillainhospitalishospitalizintussusceptionkawasakimeningitismyocardnarcolepsyreyeseizureserious adversethrombostransverse myelitisvery rare
Not recommended, contraindicated or restricted
Groups or situations the document excludes, restricts or advises against.
contraindicateddo not administerdo not useis not indicatedmust not be administeredmust not be usednot indicatednot recommendedshould be avoidedshould not be givenshould not be usedshould not receive
Animal, human or cell-line derived material
Substances sourced from animals, humans or continuous cell lines, as stated in the document.
abortedalbuminbaculovirusbloodbovinecalfcalvescaseinchickene. colieggfetalfoetalhamsterhenhenshuman albuminhuman seruminsectlactalbuminmonkeypigplasmaporcinesimiantobaccoveroyeast
Trace residues and process chemicals
Residues the document states may remain in the finished product.
2-phenoxyethanolantibioticbenzonasecetyltrimethylammoniumdeoxycholateformaldehydegentamicinglutaraldehydehost cellkanamycinmercuryneomycinovalbuminphenolpolymyxinpolysorbateresiduestreptomycinthimerosalthiomersaltracetriton
Adjuvants, carriers and immune-stimulating ingredients
Ingredients included to provoke or steer an immune response.
adjuvantaluminiumaluminumas01as03as04carrier proteincpgcrm197emulsionlipid nanoparticlemonophosphorylnanoparticleqs-21saponinsqualenetocopherol
Genetic engineering, vectors and GMOs
Where the document states genetic modification, recombinant technology or a viral vector is used.
attenuatedcell-derivedchimericdnagenetically modifiedgmolivemrnaplasmidrecombinantreverse geneticvector
Immune system, shedding and transmission
Statements about immune suppression, viral shedding or transmission to other people.
autoimmuneimmune deficiencyimmune-mediatedimmunocompromisedimmunosuppressreyeshedsheddedsheddingtransmissiontransmit
Efficacy, effectiveness and endpoints
Statements about whether and how well the product works, including surrogate endpoints and confidence intervals.
confidence intervalcorrelate of protectioneffectivenessefficacygeometric meanimmune responsenon-inferiornoninferiorseroconversionsuperiorsurrogate
What is theirs and what is ours
The three layers are kept visually separate, and it matters which is which.
- Theirs - the quotes. Set in a serif, in quotation marks, with the section number and a link. Reproduced word for word. Never paraphrased, never scored.
- Theirs, summarised - the briefing. Our sentences, but each one is a summary of a statement in that document and carries its section number. If a line cannot be traced to a section of the label, it is a fault.
- Ours - the plain English. The "In plain English" notes and the Plain English page. Definitions of a word or an ingredient. Never a judgement: no line says an ingredient or product is safe, unsafe, risky or harmless, and none says an event was caused by a vaccine.
What this site does not do
- It does not say any vaccine is unsafe. A sentence appearing here says nothing about whether an event is common, or whether it is caused by the product.
- It does not rank, score, rate or compare products.
- It does not use any source other than the manufacturer's own regulatory label for the quotations. The plain-English definitions are ours.
- It does not tell you what to do. That is a conversation with a clinician.
Real limits of this method
- Phrase matching is blunt. A sentence about a disease could match a trigger for an unrelated reason, and a serious statement worded without any listed phrase will be missed.
- Serious does not mean common. A "very rare" event in a label may have been reported once, in millions of doses, with no established cause.
- Absence is not evidence. The phrase "no data" often means a formal study was never run for a group outside the licensed population. It is not proof of harm.
- Fragment filtering is crude too. A short but important statement without a trigger phrase, or one removed as a table fragment, will not appear here.
- Only the quote is authoritative. Always read the sentence in its section, at the source.
Corrections
If a quotation here does not match the source document, it is a fault and should be treated as one. Regenerated from the source documents.